BACKGROUND AND OBJECTIVES: Investigators may have concerns that parents will not allow their children to participate in placebo-controlled trials (PCTs). The aim of the present study was to identify potential differences between parental perceptions in families who successfully completed (CO) a clinical trial compared with those who were noncompleters (NC). PATIENTS AND METHODS: Parents of both CO and NC children enrolled in pediatric gastrointestinal studies performed in the previous year were eligible. NC were defined as those who were screen failures or treatment nonresponders or had adverse events. One hundred seven parents were identified and mailed a 26-item questionnaire eliciting perceptions regarding participation in research. Questionnaires were sent 6 months after participation in research ended. RESULTS: Seventy-eight (69%) parents returned the survey. Characteristics included maternal responders (98%), English as primary language (97%), and education beyond high school (85%). Five parents (4.7%) had children involved in previous research trials. There were no significant differences in responses found between CO (n = 49; 63%) and NC (n = 29; 37%) in regard to importance of research, perceptions of risk to child, benefits to child, and more attention in the study. Statistical significance was approached in regard to the comfort with the research team, with a greater portion of CO stating that the researcher put the parent at ease and the NC feeling less positive about the interaction (P = 0.05). CONCLUSIONS: A positive perception about participation in research is not stratified by successful completion of a PCT. These results should encourage investigators and institutional review boards that if properly designed and conducted, pediatric PCTs can result in a positive experience for parents.
BACKGROUND AND OBJECTIVES: Investigators may have concerns that parents will not allow their children to participate in placebo-controlled trials (PCTs). The aim of the present study was to identify potential differences between parental perceptions in families who successfully completed (CO) a clinical trial compared with those who were noncompleters (NC). PATIENTS AND METHODS: Parents of both CO and NC children enrolled in pediatric gastrointestinal studies performed in the previous year were eligible. NC were defined as those who were screen failures or treatment nonresponders or had adverse events. One hundred seven parents were identified and mailed a 26-item questionnaire eliciting perceptions regarding participation in research. Questionnaires were sent 6 months after participation in research ended. RESULTS: Seventy-eight (69%) parents returned the survey. Characteristics included maternal responders (98%), English as primary language (97%), and education beyond high school (85%). Five parents (4.7%) had children involved in previous research trials. There were no significant differences in responses found between CO (n = 49; 63%) and NC (n = 29; 37%) in regard to importance of research, perceptions of risk to child, benefits to child, and more attention in the study. Statistical significance was approached in regard to the comfort with the research team, with a greater portion of CO stating that the researcher put the parent at ease and the NC feeling less positive about the interaction (P = 0.05). CONCLUSIONS: A positive perception about participation in research is not stratified by successful completion of a PCT. These results should encourage investigators and institutional review boards that if properly designed and conducted, pediatric PCTs can result in a positive experience for parents.
Authors: Ran D Goldman; Georg Staubli; Cristina Parra Cotanda; Julie C Brown; Julia Hoeffe; Michelle Seiler; Renana Gelernter; Jeanine E Hall; Mark A Griffiths; Adrienne L Davis; Sergio Manzano; Ahmed Mater; Sara Ahmed; David Sheridan; Matt Hansen; Samina Ali; Graham C Thompson; Naoki Shimizu; Eileen J Klein Journal: Hum Vaccin Immunother Date: 2020-11-23 Impact factor: 3.452
Authors: Alejandro Hoberman; Nader Shaikh; Sonika Bhatnagar; Mary Ann Haralam; Diana H Kearney; D Kathleen Colborn; Michelle L Kienholz; Li Wang; Clareann H Bunker; Ron Keren; Myra A Carpenter; Saul P Greenfield; Hans G Pohl; Ranjiv Mathews; Marva Moxey-Mims; Russell W Chesney Journal: JAMA Pediatr Date: 2013-06 Impact factor: 16.193